Micromet investors savor €695 million BiTE deal with Amgen
This article was originally published in Scrip
Rockville, Maryland-based Micromet inked a research deal with biotech giant Amgen for BiTE antibodies against three undisclosed solid tumour targets in exchange for €10 million up front, with the potential for the smaller firm to earn as much as €695 million (US$973 million).
Shares of Micromet climbed as high as 7.5%, or 43 cents, on 11 July, before closing at $6.18, a gain of 42 cents.
BiTE antibodies enable the body's killer T cells to recognize and attack their targets while leaving normal cells unharmed. The antibodies combine in one polypeptide chain the binding sites of two different antibodies, one of them specific for T cells, the other specific for target cells.
Under the agreement, Amgen will have the right to pursue development and commercialization of the BiTE antibodies against up to two targets. If milestones in multiple indications and tumour types are achieved, Micromet could bank up to €342 million in clinical and commercial milestone payments and is eligible to receive up to double-digit royalties on worldwide net sales.
For the second BiTE program, Micromet could receive an additional cash payment on initiation of the programme, milestones, royalties and development funding comparable to the first program.
The combined potential payments to Micromet from both programmes, excluding reimbursement of R&D costs, adds up to about €695 million, the firm said.
The company said the initial development plan contemplates €25 million in funding of Micromet R&D activities if two BiTE antibodies are advanced to the investigational new drug application stage.
All expected costs associated with the research, development and commercialization of the BiTE antibodies will be borne by Amgen.
Micromet will primarily be responsible for the discovery and preclinical development of the BiTE antibodies. Amgen will lead the clinical development, manufacturing, and commercialization of any products resulting from the collaboration.
Micromet CEO Dr Christian Itin said the collaboration aligns well with his firm's strategy to expand development of BiTE antibodies into solid tumour indications with support from a partner and brings important non-dilutive capital into the company.
Micromet has several other ongoing collaborations involving its BiTE technology.
In May 2010, the firm signed a global deal worth more than €55 million with German drug manufacturer Boehringer Ingelheim to research, develop and commercialize a new BiTE antibody to treat multiple myeloma.
Under that deal, Micromet receive €5 million cash up front, and could bank an additional €50 million and is eligible to receive a royalty comparable to profit split on the US product sales and low double-digit royalties on ex-US sales. Micromet is responsible for discovery of the product candidate and will collaborate with Boehringer on the conduct of additional preclinical trials. Boehringer is responsible for all manufacturing activities, clinical development and worldwide commercialization subject to Micromet's co-promotion right in the US.
In October 2009, Micromet entered into a global collaboration agreement with Sanofi to develop a new solid tumour BiTE antibody against an undisclosed target in exchange for €8 million up front and potentially €312 million in milestones, with €162 million of that for development and regulatory achievements and €150 million for performance-based sales milestones.
Micromet also is eligible for royalties on product sales under the Sanofi deal.
Under the terms of the agreement, Micromet is leading the discovery, research and development of the BiTE antibody through the completion of Phase I clinical trials. Beginning in Phase II, Sanofi will assume full control of clinical development and commercialization of the BiTE antibody.
Roth Capital Partners analyst Joseph Pantginis said the latest deal with Amgen “continues to be a testament, in our believe, to the potential of the BiTE platform, evidenced by the strong financial terms for drug candidates, which currently do not even exist yet”.
He noted that Micromet recently reported preliminary data from the firm’s Phase II study of blinatumomab in relapsed/refractory acute lymphoblastic leukemia (ALL), in which nine of 12 patients experienced complete remission. Enrollment in the Phase II study is ongoing to determine the dose for the expansion phase.
“We believe this study should be quite benefial in building the profile for blinatumomab,” Dr Pantginis said.
Micromet also is enrolling patients in a pivotal study in MRD-positive ALL patients in the EU, with that trial expected to complete enrolment by the end of 2012.
Additionally, the company is continuing to pursue pediatric use of the drug in added indications, Dr Pantginis pointed out.